Surgical method and apparatus

ABSTRACT

A method of conducting traditional two-handed phacoemulsification through two relatively small incisions by using a phacoemulsification tip/sleeve with reduced diameter along with a second irrigation tip, with or without an attached manipulation tool.

This application is a continuation-in-part of U.S. patent applicationSer. No. 10/937,065, filed Sep. 9, 2004, currently co-pending.

BACKGROUND OF THE INVENTION

This invention relates generally to the field of cataract surgery andmore particularly to a method and apparatus for bi-manualphacoemulsification surgery.

The human eye in its simplest terms functions to provide vision bytransmitting light through a clear outer portion called the cornea, andfocusing the image by way of the lens onto the retina. The quality ofthe focused image depends on many factors including the size and shapeof the eye, and the transparency of the cornea and lens.

When age or disease causes the lens to become less transparent, visiondeteriorates because of the diminished light that can be transmitted tothe retina. This deficiency in the lens of the eye is medically known asa cataract. An accepted treatment for this condition is surgical removalof the lens and replacement of the lens function by an artificialintraocular lens (IOL).

In the United States, the majority of cataractous lenses are removed bya surgical technique called phacoemulsification. A typical surgicalhandpiece suitable for phacoemulsification procedures consists of anultrasonically driven handpiece, an attached cutting tip, and irrigatingsleeve and an electronic control console. The handpiece assembly isattached to the control console by an electric cable and flexibletubings. Through the electric cable, the console varies the power leveltransmitted by the handpiece to the attached cutting tip and theflexible tubings supply irrigation fluid to and draw aspiration fluidfrom the eye through the handpiece assembly.

The operative part of the handpiece is a centrally located, hollowresonating bar or horn directly attached to a set of piezoelectriccrystals. The crystals supply the required ultrasonic vibration neededto drive both the horn and the attached cutting tip duringphacoemulsification and are controlled by the console. The crystal/hornassembly is suspended within the hollow body or shell of the handpieceby flexible mountings. The handpiece body terminates in a reduceddiameter portion or nosecone at the body's distal end. The nosecone isexternally threaded to accept the irrigation sleeve. Likewise, the hornbore is internally threaded at its distal end to receive the externalthreads of the cutting tip. The irrigation sleeve also has an internallythreaded bore that is screwed onto the external threads of the nosecone.The cutting tip is adjusted so that the tip projects only apredetermined amount past the open end of the irrigating sleeve

A modified phacoemulsification technique called “bimanual”phacoemulsification has been adopted by many surgeons. With the bimanualtechnique, the irrigation sleeve is removed from around theultrasonically drive tip. This allows for the small tip to be insertedinto the eye through a smaller incision. Irrigation fluid is supplied bya second irrigating tip. Additional information concerning traditionalphacoemulsification and bimanual phacoemulsification is included in U.S.patent Publication No. US 2003/0004455 A1. And in particular, Paragraphs[0001] through [0008], which are incorporated herein by reference. Asdescribed in this reference, traditional phacoemulsificationtips/irrigation sleeves have a larger overall diameter, requiring alarger incision. Traditional phacoemulsification tips/irrigation sleevesare also described as causing “roiling” in the area immediately in frontof the phaco tip, and visibility-reducing “clouding” of debris.According to this reference, a bi-manual technique solves these andother problems. In the bimanual technique, the incision may be smallerbecause the irrigation sleeve on the ultrasonic tip is not used, butwithout the sleeve, there is direct contact between the vibrating tipand the tissue at the wound. This can result in extra stress on thewound tissue, delaying healing and possibly requiring the use of asuture to seal the wound at the completion of surgery. The softirrigation sleeve also acts to seal the wound from leakage duringsurgery. Without the use of the irrigation sleeve, excessive woundleakage can cause shallowing of the anterior chamber, excessiveturbulence and premature removal of the protective viscoelasticmaterial. Excessive wound leakage can also cause over-hydration of thewound tissue, possibly resulting in edema.

Therefore, a need continues to exist for a method and device forconducting phacoemulsification through a small incision.

BRIEF SUMMARY OF THE INVENTION

The inventors of the present invention have discovered that traditionalone-handed phacoemulsification can be conducted through a relativelysmall incision by reducing the diameter of the phacoemulsificationtip/sleeve. A second irrigation tip, with or without an attachedmanipulation tool, may also be used to provide addition irrigation. Suchan arrangement minimizes wound leakage, thereby helping to avoidover-hydration of the wound, low intraocular pressure, excessiveturbulence and premature removal of the viscoelastic material.

Accordingly, one objective of the present invention is to provide amethod for two-handed phacoemulsification with irrigation directedthrough both incisions.

Another objective of the present invention is to provide a smallincision phacoemulsification method and apparatus having reduced woundleakage.

Another objective of the present invention is to provide a smallincision phacoemulsification method and apparatus having reducedturbulence.

Another objective of the present invention is to provide a smallincision phacoemulsification method and apparatus that minimizedpremature removal of the viscoelastic material.

Another objective of the present invention is to provide a smallincision phacoemulsification method and apparatus that minimizes woundhydration.

These and other advantages and objectives of the present invention willbecome apparent from the detailed description and claims that follow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a partial cross-section of the phacoemulsification andirrigation/aspiration tips that may be used with the present invention.

FIG. 2 is a schematic illustration of a phacoemulsification handpieceand irrigation/aspiration handpiece being used for a traditionalbi-manual phacoemulsification surgical procedure.

FIG. 3 is a schematic illustration of a phacoemulsification handpieceand irrigation handpiece being used for the bi-manualphacoemulsification surgical procedure of the present invention.

FIG. 4 is a partial cross-sectional view of the irrigation handpiece ofthe present invention.

DETAILED DESCRIPTION OF THE INVENTION

As seen in FIGS. 1 and 3, the method of the present invention isgenerally practiced using irrigation tip 10 and phacoemulsification tip12 simultaneously in what is called a “Bi-Manual” surgical technique.Irrigation tip 10 may be any conventional irrigation tip and may includeirrigation port 17 and flexible outer silicone sleeve 14 and inner tube16. Inner tube 16 may also be formed with hook 15 or some othermanipulation device. Space 18 between sleeve 14 and tube 16 defines apathway for irrigating solution to flow out port 20 and into thesurgical site. Port 17 can be used as an additional irrigation port, andirrigating solution may be expressed out of ports 17 and 20.Alternatively, as seen in FIG. 4, tip 110 may have solid hook or tool115, with no irrigation port. Irrigation fluid flows in space 118between sleeve 114 and tool 115. Phacoemulsification tip 12 is ofsimilar construction and generally contains flexible outer siliconesleeve 22 and inner tube 24 defining a first irrigating fluid path 26that allows irrigating fluid to flow out of port 30. Inner tube 24contains open distal end 28 allowing material to be aspirated throughinner tube 24. Preferably, phacoemulsification tip 12 has a reducedoverall diameter, on the order of 0.8 mm to 1.0 mm. Such a smalldiameter permits an incision size of preferably less than around 2.4 mmin width, even more preferably less than around 2.2 mm in width, andeven more preferably less than around 2.0 mm in width, and even morepreferably less than around 1.8 mm in width and most preferably lessthan around 1.6 mm in width. Alternatively, tip may be a liquefracturingtip similar to the AQUALASE® tip sold by Alcon Laboratories, Inc., FortWorth, Tex. and described more fully in U.S. Pat. No. 6,579,270 B2(Sussman, et al.) at FIGS. 23 and 24 and column 7, lines 32-45, thecontents of which being incorporated herein by reference.

As best seen in FIG. 2, in a traditional bimanual phacoemulsificationtechnique, irrigation/aspiration handpiece 100 is connected topressurized or elevated source of irrigation fluid 102 through tubing103. Ultrasound handpiece 104 is connected to aspiration pump 106through tubing 105 and to ultrasound driver 107 through cable 109.Ultrasound handpiece 104 is not connected to source 102 and does nothave any irrigation capabilities.

As seen in FIGS. 1 and 3, in use, irrigation handpiece 200, having tip10, is connected to pressurized or elevated source of irrigation fluid202 through tubing 203. Ultrasound handpiece 204, having tip 12, isconnected to aspiration pump 206 through tubing 205, to source 202through tubing 207 and fitting 208 and to ultrasound driver 207 throughcable 209. Accordingly, both handpiece 200 and handpiece 204 have acommon irrigation source and both provide an irrigation function.Irrigation tip 10 is held in one hand by the surgeon and used in aconventional manner to provide an irrigating fluid, such as a salinesolution, into eye 32 to help maintain the integrity of the eye andprevent anterior chamber collapse. Phacoemulsification tip 12 is held inthe other hand by the surgeon and is connected to a suitable ultrasoundhandpiece. One suitable handpiece is the INFINITI® system handpieceavailable commercially from by Alcon Laboratories, Inc., Worth, Tex.Phacoemulsification tip 12 is used to conduct a traditionalphacoemulsification technique during which an irrigating fluid, such asa saline solution, is introduced into eye 32 through fluid path 26 andport 30 and debris is aspirated from eye 32 through distal end 28 andinner tube 24. Such an arrangement prevents direct contact betweenvibrating inner tube 24.

This description is given for purposes of illustration and explanation.It will be apparent to those skilled in the relevant art that changesand modifications may be made to the invention described above withoutdeparting from its scope or spirit.

1. A surgical method, comprising the steps of: a) introducing a firstirrigation tip into a surgical site, the irrigation tip having a firstinner tube covered by a first outer flexible sleeve, a space between thefirst inner tube and the first outer sleeve creating a first irrigationfluid path; b) introducing a second tip into the surgical site throughan incision of less than around 2.4 mm in width, the second tip having ahollow second inner tube covered by a second outer flexible sleeve, aspace between the second inner tube and the second outer sleeve creatinga second irrigation fluid path; c) providing irrigating fluid to thesurgical site through both the first irrigation path and the secondirrigation path; d) vibrating the second inner tube; and e) aspiratingmaterial from the surgical site through the second hollow inner tube. 2.The method of claim 1 wherein the irrigating fluid is provided to thesurgical site through both the first irrigation path and the secondirrigation path from a common source of irrigation fluid.
 3. The methodof claim 1 wherein the incision is less than around 2.2 mm in width. 4.The method of claim 1 wherein the incision is less than around 2.0 mm inwidth.
 5. The method of claim 1 wherein the incision is less than around1.8 mm in width.
 6. The method of claim 1 wherein the incision is lessthan around 1.6 mm in width.
 7. The method of claim 1 wherein theincision is between around 1.6 mm and 2.4 mm in width.
 8. A surgicalapparatus, comprising: a) a first irrigation handpiece having anirrigation tip, the irrigation tip having a first inner tube covered bya first outer flexible sleeve, a space between the first inner tube andthe first outer sleeve creating a first irrigation fluid path; b) asecond handpiece having a tip, the tip having a hollow second inner tubecovered by a second outer flexible sleeve, a space between the secondinner tube and the second outer sleeve creating a second irrigationfluid path the second outer sleeve being sized so at to permit the tipof the second handpiece to pass through an incision of less than 2.4 mmin width; c) the first irrigation handpiece and the second handpiecebeing connected to at least one source of irrigation fluid so as toprovide irrigating fluid to the surgical site through both the firstirrigation path and the second irrigation path; d) an ultrasound driverconnected to the second handpiece so as to vibrate the second innertube; and e) as aspiration pump connected to the second tube so as toaspirate material from the surgical site through the second hollow innertube.
 9. The apparatus of claim 8 wherein the irrigating fluid isprovided to the surgical site through both the first irrigation path andthe second irrigation path from a common source of irrigation fluid. 10.The apparatus of claim 8 wherein the incision is less than around 2.2 mmin width.
 11. The apparatus of claim 8 wherein the incision is less thanaround 2.0 mm in width.
 12. The apparatus of claim 8 wherein theincision is less than around 1.8 mm in width.
 13. The apparatus of claim8 wherein the incision is less than around 1.6 mm in width.
 14. Theapparatus of claim 8 wherein the incision is between around 1.6 mm and2.4 mm in width.
 15. A surgical method, comprising the steps of: a)introducing a first irrigation tip into a surgical site, the irrigationtip having a first inner tube covered by a first outer flexible sleeve,a space between the first inner tube and the first outer sleeve creatinga first irrigation fluid path; b) introducing a second tip into thesurgical site through an incision of less than around 2.4 mm in width,the second tip having a hollow second inner tube covered by a secondouter flexible sleeve, a space between the second inner tube and thesecond outer sleeve creating a second irrigation fluid path; c)providing irrigating fluid to the surgical site through both the firstirrigation path and the second irrigation path; and d) aspiratingmaterial from the surgical site through the second hollow inner tube.16. The method of claim 15 wherein the irrigating fluid is provided tothe surgical site through both the first irrigation path and the secondirrigation path from a common source of irrigation fluid.
 17. The methodof claim 15 wherein the incision is less than around 2.2 mm in width.18. The method of claim 15 wherein the incision is less than around 2.0mm in width.
 19. The method of claim 15 wherein the incision is lessthan around 1.8 mm in width.
 20. The method of claim 15 wherein theincision is less than around 1.6 mm in width.
 21. The method of claim 15wherein the incision is between around 1.6 mm and 2.4 mm in width.